drugset / Trial / NCT01613664
Efficiency of TISSEEL for Sleeve Gastrectomy Complications
RandomizedParallel-groupSingle-blindTreatment
Summary
Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice in the surgical management of patients with morbid obesity. However, this restrictive procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage (1%) and intra-abdominal loco regional collections (1%). At present, there is no sufficiently reliable technique to prevent these complications.
Timeline
- Start
- 2014-02
- Primary completion
- 2018-05-15
- Completion
- 2018-05-15
Publications
- Background Pequignot A, Fuks D, Verhaeghe P, Dhahri A, Brehant O, Bartoli E, Delcenserie R, Yzet T, Regimbeau JM. Is there a place for pigtail drains in the management of gastric leaks after laparoscopic sleeve gastrectomy? Obes Surg. 2012 May;22(5):712-20. doi: 10.1007/s11695-012-0597-0.
- Background Pequignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.
- Background Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016. No abstract available.
- Background Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10.
- Background Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30.
- Rebibo L, Dhahri A, Chati R, Cosse C, Huet E, Regimbeau JM. Effectiveness of Fibrin Sealant Application on the Development of Staple Line Complications After Sleeve Gastrectomy: A Prospective Randomized Trial. Ann Surg. 2018 Nov;268(5):762-768. doi: 10.1097/SLA.0000000000002892.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fibrinogen Concentrate Human | Protein / enzyme biologic | 2 ml | — |